Those who are now buying InVivo (NVIV) at these sale prices will be richly rewarded in the coming three to nine months. For a biotech stock this is very short time frame to wait. Let’s get to the facts…
Fact 1: Currently there is nothing approved that can restore function to patients with traumatic Spinal Cord Injury (SCI, paralysis). Each year $10 billion is spent on patients with acute SCI, so the market potential is huge.
Fact 2: InVivo’s polymer-based medical treatments have been successful in restoring, within three to five weeks, functional improvement in more than 40 paralyzed green monkeys. No other company has ever restored function to a single paralyzed monkey.
Fact 3: The DNA in green monkeys is a 98% match to the DNA in humans so there is an overwhelming chance that this will work just as well in humans. Clinical trials in humans will begin in early 2013.
Fact 4: InVivo’s “scaffold” is a biopolymer material already approved by the FDA for other uses, such a sutures, that ultimately dissolve into CO2 and water.
Fact 5: In April 2012, the FDA confirmed that the Company’s biopolymer scaffolding device can indeed be considered a medical device (not a pharmaceutical) and therefore follow the pathway for an Investigational Device Exemption. The FDA will allow the device to proceed along the Humanitarian Use Device/Humanitarian Device Exemption pathway. This means that the Company might only have to try this on as few as 5 patients before receiving FDA approval for the device to be marketed for humanitarian use while testing continues.
Fact 6: On May 9, 2012, Frank M. Reynolds, the Chief Executive Officer of InVivo Therapeutics Holdings Corp., terminated his previously disclosed Rule 10b5-1 trading plan, which covered potential sales of up to 4,000,000 shares of common stock of the Company. No sales were made pursuant to the Rule 10b5-1 Plan. Frank has not sold a share since April 2012 and previous sales were due to a one-time personal reason and had nothing to do with future company performance.